Entacapone (n=87) | Placebo (n=38) | ||||
---|---|---|---|---|---|
Variables | Baseline (n=87) | Mean, months 4 and 6 (n=78) | Baseline (n=38) | Mean, months 4 and 6 (n=37) | Entacapone v placebo* |
Values are mean (SD). | |||||
*Intention to treat-observed cases analysis. | |||||
ADL, activities of daily living; UPDRS, unified Parkinson’s disease rating scale. | |||||
Primary efficacy variable | |||||
UPDRS | |||||
ADL† (part II) | 10.6 (5.7) | 10.0 (5.7) | 9.5 (4.2) | 9.4 (5.7) | p<0.01 |
Secondary efficacy variables | |||||
UPDRS | |||||
Mentation, behaviour, mood (part I) | 1.5 (1.5) | 1.8 (1.5) | 1.2 (1.3) | 1.1 (1.1) | NS |
Motor score (part III) | 23.4 (11.7) | 20.9 (12.4) | 22.4 (9.8) | 17.4 (10.2) | NS |
Total score (I, II, and III) | 35.2 (16.6) | 32.7 (17.5) | 33.0 (12.5) | 27.8 (14.5) | NS |
Scheduled levodopa dose (mg/d) | 503 (259) | 510 (253) | 522 (343) | 569 (365) | p<0.01 |